标准编号:ISO 16571:2024

中文名称:医疗器械产生的羽流的疏散系统

英文名称:Systems for evacuation of plume generated by medical devices

发布日期:2024-03

标准范围

1.1 This document specifies requirements and guidelines for systems and equipment used to evacuate plume generated by medical devices. 1.2 This document applies to all types of plume evacuation systems (PESs), including a) portable; b) mobile; c) stationary, including dedicated central pipelines; d) PESs integrated into other equipment; e) PESs for endoscopic procedures (e.g., minimally invasive, laparoscopic). 1.3 This document applies to all healthcare facilities where PESs are used, including, but not limited to a) surgical facilities; b) medical offices; c) cosmetic treatment facilities; d) medical teaching facilities; e) dental clinics; f) veterinary facilities. 1.4 This document provides guidance on the following aspects of PESs: a) importance;b) purchasing; c) design; d) manufacture; e) documentation; f) function; g) performance; h) installation; i) commissioning; j) testing; k) training;

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